Aorto-ostial Coronary LesionsOSTIALNCT07835048
The OSTIAL Study (Optimization of Stent Placement in Aorto-ostial Lesions)
A study testing Coronary angioplasty using the floating balloon technique and Coronary angioplasty without the floating-balloon technique in people with Aorto-ostial Coronary Lesions and Coronary Angioplasty, run by Centre Cardiologique du Nord at 6 sites in France.
Trial summary
Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-ostial Coronary Lesions, Coronary Angioplasty, Floating Balloon" (FB) Technique
- What is being tested?
- Coronary angioplasty using the floating balloon technique and Coronary angioplasty without the floating-balloon technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Oct 2026to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged over 18 years
- Prospective part: Patient who has signed an informed consent form
- Retrospective part: No objection to the use of personal data for this research
- Indication for coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) for patients included in the prospective part / Patients in the historical part who underwent coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) using the "floating balloon" (FB) technique, followed by a CCTA assessment of positioning
- Affiliation with or beneficiary of a social security scheme.
Who cannot join
- Contraindication to coronary CT angiography (severe renal impairment not requiring dialysis (GFR ≤ 30 ml/min)), applicable only to patients included in the prospective part
- Refusal of consent (patients included in the prospective part)
- Objection to the use of personal data (patients in the retrospective part)
- Patient unable to read, write, or understand French
- Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
- Adult patient placed under guardianship, curatorship, or judicial protection
- Patient unable to personally provide consent pursuant to Article L.1121-8 of the CSP, or an adult under legal protection
- Pregnant or breastfeeding woman as defined by Article L1121-5 of the CSP
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites
Hôpital privé Bois Bernard
Bois-Bernard
Sina POROUCHANI, Dr, 0683575767, sina.porouchani@gmail.com
CHU Clermont-Ferrand
Clermont-Ferrand
Géraud SOUTEYRAND, Dr, 0473751410, gsouteyrand@chu-clermontferrand.fr
GHPSO Creil
Creil
Salim SB BELGUIDOUM, Dr, 0661332746, salim_0101@hotmail.fr
Institut Cardiovasculaire Paris Sud - Massy
Massy
Nicolas Amabile, 0612523423, nicolasamabile@yahoo.fr
Centre cardiologique du nord
Saint-Denis
Frank FD DIGNE, PHD, 01 49 33 41 13, f.digne@ccn.fr
Karima KM MOUSSOUNI, Cra, 0679145144
CHU de saint étienne
Saint-Etienne
Marouane BOUKHRIS, Dr, 0650278487, marouaneboukhris1@gmail.com
About this study
Official title: Optimisation du Positionnement Des Stents Dans Les lésions Aorto-ostiales : étude Multicentrique Historico-prospective Avec Phase randomisée Comparant l'Angioplastie Coronaire Avec ou Sans Technique du Floating Ballon Étude OSTIAL (Optimizing Stent In Aorto-Ostial Lesion)
Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment.
Despite the angiographic appearance being deemed optimal, several studies have shown a high rate of suboptimal stent positioning at the ostium when subsequent coronary CT angiography (CCTA) assessment is performed.
Read more
This suboptimal positioning may be linked to incomplete ostial coverage, which could increase the risk of in-stent restenosis. It may also be linked to excessive stent protrusion into the aorta, which could compromise future procedures, particularly in the context of transcatheter aortic valve replacement.
The "Floating Balloon" (FB) technique has been developed to improve system stability and to reliably mark the aorto-ostial landing zone (AOLZ). A previous study demonstrated the feasibility and accuracy of this technique.
The aim of the current study is to assess the clinical effectiveness of the Floating Balloon. Although this technique is already in use, no study has yet conducted a systematic assessment of stent positioning using CCTA.
The study utilised a combined retrospective-prospective approach to comprehensively evaluate the incidence of suboptimal stent positioning associated with the Floating Balloon technique. This evaluation was conducted by systematically comparing patient outcomes between those treated with the FB and those treated without the FB. The study employed CCTA as a key tool to assess stent position, ensuring a precise analysis of the data.
To achieve this, it is recommended that follow-up data from patients who have already undergone the FB procedure and had their stent position assessed via CCTA (retrospective component) be analysed, while also enrolling new patients and randomizing them into FB and non-FB groups (prospective component).
Read the detailed description
In order to address the primary objective (namely, to estimate the rate of stent malpositioning), 97 evaluable subjects are required to achieve a precision (half-width of the 95% confidence interval) of +/-10% (assuming a conservative 50% rate of correct positioning).
As assessments are conducted immediately after the procedure, the investigators do not anticipate a significant number of non-evaluable subjects. The proposal is to enrol N=100 subjects in the FB group, with 50 subjects in the retrospective phase and another 50 in the prospective phase.
In order to address the secondary objective of comparing malpositioning rates between the two groups (with and without FB), patients in the non-FB group should be enrolled at a 1:2 ratio. The justification for this number is based on feasibility. This will provide preliminary data for the non-FB group.
Therefore, given our retrospective cohort of 50 FB subjects with available measurements, the prospective phase will include N=50 + 25-or 75 additional subjects (50 in the FB arm and 25 in the non-FB arm). The analyses will therefore cover a total of 125 subjects (100 with FB and 25 without FB).
- Being tested
- Coronary angioplasty using the floating balloon technique, Coronary angioplasty without the floating-balloon technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angioplasty using the floating balloon techniqueProcedure or surgery
Coronary angioplasty using the FB technique involves the following steps:
- Crossing the aorto-ostial lesion using a standard coronary guidewire positioned in the target artery.
- Withdrawing the guiding catheter from the ostium and placing a second guidewire, formed into a loop, within the aortic root.
- Inflating a small-diameter (2 mm) balloon in the aorta over the second guidewire; this serves as the "floating balloon."
- Advancing the stent toward the target lesion.
- Gradually withdrawing the floating balloon until its proximal marker contacts the tip of the guiding catheter, thereby defining the aorto-ostial plane and the aorto-ostial landing zone (AOLZ).
- Maintaining forward pressure on the guiding catheter to stabilize the entire system and limit selective engagement of the ostium.
- Aligning the stent's proximal marker with the balloon marker and the tip of the guiding catheter, followed by gradual deployment of the stent.
Coronary angioplasty without the floating-balloon techniqueProcedure or surgery
Angioplasty of the aorto-ostial lesion without the jailed-balloon (FB) technique will be performed as follows:
- Coronary catheterization via the access route chosen by the operator
- Predilatation, if deemed necessary
- Implantation of a drug-eluting stent (DES) sized according to angiographic or QCA assessment
- Final optimization (post-dilatation, POT, or other techniques) at the operator's discretion
| Study group | Role | What they receive |
|---|---|---|
| Coronary angioplasty using the floating balloon technique | Experimental | Not described Receives: Procedure: Coronary angioplasty using the floating balloon technique |
| Coronary angioplasty without the floating-balloon technique | Active comparator | Not described Receives: Procedure: Coronary angioplasty without the floating-balloon technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants in whom stent placement was technically successful and who were evaluated by CT scan.
Measured: At the end of the procedure
Secondary outcomes (1)
The secondary outcome is the rate of major adverse cardiovascular events (MACE).
The secondary outcome is the rate of major adverse cardiovascular events (MACE), including cardiac mortality, all-cause mortality, myocardial infarction (MI), target lesion revascularization (TLR) and hospitalisation for cardiovascular causes.
Measured: 12 months after the surgery procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aorto-ostial Coronary LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank FD DIGNE, PHD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835048
- Sponsor's protocol ID
- 2026-A01154-47
- Acronym
- OSTIAL
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Digne F, Darmon A, Belguidoum S, Nejjari M, Feignoux J. Optimizing Stent Placement in Ostial Coronary Lesions With the Floating Balloon Technique: The OSTIAL (Optimizing Stent In Aorto-Ostial Lesion) Pivotal Study. Catheter Cardiovasc Interv. 2025 Apr;105(5):1269-1277. doi: 10.1002/ccd.31449. Epub 2025 Feb 17.
PubMed 39962791Digne F, Darmon A, Nejjari M. Optimizing Stent Placement in Aorto-Ostial Lesions: Introducing the New Floating Balloon Technique. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2082-2084. doi: 10.1016/j.jcin.2024.06.025. Epub 2024 Aug 21. No abstract available.
PubMed 39177558Jaffe R, Halon DA, Shiran A, Rubinshtein R. Percutaneous treatment of aorto-ostial coronary lesions: Current challenges and future directions. Int J Cardiol. 2015;186:61-6. doi: 10.1016/j.ijcard.2015.03.161. Epub 2015 Mar 17.
PubMed 25814346Yamamoto K, Sato T, Salem H, Matsumura M, Fall KN, Prasad M, Ng VG, Sethi SS, Nazif TM, Parikh SA, Vahl TP, Ali ZA, Karmpaliotis D, Rabbani LE, Collins MB, Leon MB, McEntegart MB, Moses JW, Kirtane AJ, Mintz GS, Maehara A. Mechanisms and treatment outcomes of ostial right coronary artery in-stent restenosis. EuroIntervention. 2023 Aug 7;19(5):e383-e393. doi: 10.4244/EIJ-D-23-00107.
PubMed 37283548Freeman M, Clark DJ, Andrianopoulos N, Duffy SJ, Lim HS, Brennan A, Charter K, Shaw J, Horrigan M, Ajani AE, Sebastian M, Reid CM, Farouque HM; Melbourne Interventional Group. Outcomes after percutaneous coronary intervention of ostial lesions in the era of drug-eluting stents. Catheter Cardiovasc Interv. 2009 May 1;73(6):763-8. doi: 10.1002/ccd.21941.
PubMed 19309731Rubinshtein R, Ben-Dov N, Halon DA, Lavi I, Finkelstein A, Lewis BS, Jaffe R. Geographic miss with aorto-ostial coronary stent implantation: insights from high-resolution coronary computed tomography angiography. EuroIntervention. 2015 Jul;11(3):301-7. doi: 10.4244/EIJV11I3A57.
PubMed 24694540Dishmon DA, Elhaddi A, Packard K, Gupta V, Fischell TA. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease. J Invasive Cardiol. 2011 Aug;23(8):322-6.
PubMed 21828393
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation du Positionnement Des Stents Dans Les lésions Aorto-ostiales : étude Multicentrique Historico-prospective Avec Phase randomisée Comparant l'Angioplastie Coronaire Avec ou Sans Technique du Floating Ballon Étude OSTIAL (Optimizing Stent In Aorto-Ostial Lesion)
- ClinicalTrials.gov ID
- NCT07835048
- Acronym / sponsor ID
- OSTIAL / 2026-A01154-47
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aorto-ostial coronary lesions present a significant challenge during coronary angioplasty. This is due to the difficulty of precisely identifying the aorto-ostial plane and the frequent instability of the guiding catheter during stent deployment.
Despite the angiographic appearance being deemed optimal, several studies have shown a high rate of suboptimal stent positioning at the ostium when subsequent coronary CT angiography (CCTA) assessment is performed.
This suboptimal positioning may be linked to incomplete ostial coverage, which could increase the risk of in-stent restenosis. It may also be linked to excessive stent protrusion into the aorta, which could compromise future procedures, particularly in the context of transcatheter aortic valve replacement.
The "Floating Balloon" (FB) technique has been developed to improve system stability and to reliably mark the aorto-ostial landing zone (AOLZ). A previous study demonstrated the feasibility and accuracy of this technique.
The aim of the current study is to assess the clinical effectiveness of the Floating Balloon. Although this technique is already in use, no study has yet conducted a systematic assessment of stent positioning using CCTA.
The study utilised a combined retrospective-prospective approach to comprehensively evaluate the incidence of suboptimal stent positioning associated with the Floating Balloon technique. This evaluation was conducted by systematically comparing patient outcomes between those treated with the FB and those treated without the FB. The study employed CCTA as a key tool to assess stent position, ensuring a precise analysis of the data.
To achieve this, it is recommended that follow-up data from patients who have already undergone the FB procedure and had their stent position assessed via CCTA (retrospective component) be analysed, while also enrolling new patients and randomizing them into FB and non-FB groups (prospective component).
Detailed description
In order to address the primary objective (namely, to estimate the rate of stent malpositioning), 97 evaluable subjects are required to achieve a precision (half-width of the 95% confidence interval) of +/-10% (assuming a conservative 50% rate of correct positioning).
As assessments are conducted immediately after the procedure, the investigators do not anticipate a significant number of non-evaluable subjects. The proposal is to enrol N=100 subjects in the FB group, with 50 subjects in the retrospective phase and another 50 in the prospective phase.
In order to address the secondary objective of comparing malpositioning rates between the two groups (with and without FB), patients in the non-FB group should be enrolled at a 1:2 ratio. The justification for this number is based on feasibility. This will provide preliminary data for the non-FB group.
Therefore, given our retrospective cohort of 50 FB subjects with available measurements, the prospective phase will include N=50 + 25-or 75 additional subjects (50 in the FB arm and 25 in the non-FB arm). The analyses will therefore cover a total of 125 subjects (100 with FB and 25 without FB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary angioplasty using the floating balloon technique | Experimental | Procedure: Coronary angioplasty using the floating balloon technique |
| Coronary angioplasty without the floating-balloon technique | Active comparator | Procedure: Coronary angioplasty without the floating-balloon technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged over 18 years
- Prospective part: Patient who has signed an informed consent form
- Retrospective part: No objection to the use of personal data for this research
- Indication for coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) for patients included in the prospective part / Patients in the historical part who underwent coronary angioplasty for an aorto-ostial lesion (right coronary artery or left main coronary artery) using the "floating balloon" (FB) technique, followed by a CCTA assessment of positioning
- Affiliation with or beneficiary of a social security scheme.
Key exclusion criteria (8 listed)
- Contraindication to coronary CT angiography (severe renal impairment not requiring dialysis (GFR ≤ 30 ml/min)), applicable only to patients included in the prospective part
- Refusal of consent (patients included in the prospective part)
- Objection to the use of personal data (patients in the retrospective part)
- Patient unable to read, write, or understand French
- Vulnerable patient as defined by Article L1121-6 of the Public Health Code (CSP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angioplasty using the floating balloon techniqueCoronary angioplasty using the FB technique involves the following steps: 1. Crossing the aorto-ostial lesion using a standard coronary guidewire positioned in the target artery. 2. Withdrawing the guiding catheter from the ostium and placing a second guidewire, formed into a loop, within the aortic root. 3. Inflating a small-diameter (2 mm) balloon in the aorta over the second guidewire; this serves as the "floating balloon." 4. Advancing the stent toward the target lesion. 5. Gradually withdrawing the floating balloon until its proximal marker contacts the tip of the guiding catheter, thereby defining the aorto-ostial plane and the aorto-ostial landing zone (AOLZ). 6. Maintaining forward pressure on the guiding catheter to stabilize the entire system and limit selective engagement of the ostium. 7. Aligning the stent's proximal marker with the balloon marker and the tip of the guiding catheter, followed by gradual deployment of the stent. | Procedure or surgery | Coronary angioplasty using the floating balloon technique |
| Coronary angioplasty without the floating-balloon techniqueAngioplasty of the aorto-ostial lesion without the jailed-balloon (FB) technique will be performed as follows: 1. Coronary catheterization via the access route chosen by the operator 2. Predilatation, if deemed necessary 3. Implantation of a drug-eluting stent (DES) sized according to angiographic or QCA assessment 4. Final optimization (post-dilatation, POT, or other techniques) at the operator's discretion | Procedure or surgery | Coronary angioplasty without the floating-balloon technique |
Primary outcome
The number of participants in whom stent placement was technically successful and who were evaluated by CT scan.
Time frame: At the end of the procedure
1 secondary outcome
The secondary outcome is the rate of major adverse cardiovascular events (MACE).
Time frame: 12 months after the surgery procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 39962791Digne F, Darmon A, Belguidoum S, Nejjari M, Feignoux J. Optimizing Stent Placement in Ostial Coronary Lesions With the Floating Balloon Technique: The OSTIAL (Optimizing Stent In Aorto-Ostial Lesion) Pivotal Study. Catheter Cardiovasc Interv. 2025 Apr;105(5):1269-1277. doi: 10.1002/ccd.31449. Epub 2025 Feb 17.
- Background: PubMed 39177558Digne F, Darmon A, Nejjari M. Optimizing Stent Placement in Aorto-Ostial Lesions: Introducing the New Floating Balloon Technique. JACC Cardiovasc Interv. 2024 Sep 9;17(17):2082-2084. doi: 10.1016/j.jcin.2024.06.025. Epub 2024 Aug 21. No abstract available.
- Background: PubMed 25814346Jaffe R, Halon DA, Shiran A, Rubinshtein R. Percutaneous treatment of aorto-ostial coronary lesions: Current challenges and future directions. Int J Cardiol. 2015;186:61-6. doi: 10.1016/j.ijcard.2015.03.161. Epub 2015 Mar 17.
- Background: PubMed 37283548Yamamoto K, Sato T, Salem H, Matsumura M, Fall KN, Prasad M, Ng VG, Sethi SS, Nazif TM, Parikh SA, Vahl TP, Ali ZA, Karmpaliotis D, Rabbani LE, Collins MB, Leon MB, McEntegart MB, Moses JW, Kirtane AJ, Mintz GS, Maehara A. Mechanisms and treatment outcomes of ostial right coronary artery in-stent restenosis. EuroIntervention. 2023 Aug 7;19(5):e383-e393. doi: 10.4244/EIJ-D-23-00107.
- Background: PubMed 19309731Freeman M, Clark DJ, Andrianopoulos N, Duffy SJ, Lim HS, Brennan A, Charter K, Shaw J, Horrigan M, Ajani AE, Sebastian M, Reid CM, Farouque HM; Melbourne Interventional Group. Outcomes after percutaneous coronary intervention of ostial lesions in the era of drug-eluting stents. Catheter Cardiovasc Interv. 2009 May 1;73(6):763-8. doi: 10.1002/ccd.21941.
- Background: PubMed 24694540Rubinshtein R, Ben-Dov N, Halon DA, Lavi I, Finkelstein A, Lewis BS, Jaffe R. Geographic miss with aorto-ostial coronary stent implantation: insights from high-resolution coronary computed tomography angiography. EuroIntervention. 2015 Jul;11(3):301-7. doi: 10.4244/EIJV11I3A57.
- Background: PubMed 21828393Dishmon DA, Elhaddi A, Packard K, Gupta V, Fischell TA. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease. J Invasive Cardiol. 2011 Aug;23(8):322-6.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank FD DIGNE, PHD principal investigator
Centre Cardiologique du Nord
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary angioplasty using the floating balloon technique and Coronary angioplasty without the floating-balloon technique in people with Aorto-ostial Coronary Lesions and Coronary Angioplasty, run by Centre Cardiologique du Nord at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank FD DIGNE, PHD (01 49 33 41 13, f.digne@ccn.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants in whom stent placement was technically successful and who were evaluated by CT scan. (time frame: At the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07835048, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.